ENZYMUN TEST(R) T4 (TOTAL THYROXINE)— 510(k) K901086

Name: FDA 510(k) clearance K901086
Creator: U.S. Food and Drug Administration
Published: 1990-03-30

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K901086 for ENZYMUN TEST(R) T4 (TOTAL THYROXINE), Substantially Equivalent on 1990-03-30. Applicant: Boehringer Mannheim Corp.. Device class: 2.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code KLT
Device class: Class 2
Regulation: 21 CFR 862.3645
Advisory panel: Clinical Toxicology
Date received: 1990-03-09
Decision date: 1990-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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